GHIT and EDCTP co-invest additional 7.8 million Euro in the Pediatric Praziquantel Consortium's access program to ensure treatment of schistosomiasis for preschool-aged children
The Global Health Innovative Technology Fund (GHIT) and The European & Developing Countries Clinical Trials Partnership (EDCTP) jointly announced new co-investments of JPY 262 million (EUR 2.1 million) for two years and EUR 5.7 million for five years, respectively, in the Pediatric Praziquantel Consortium's ADOPT program – an implementation research study to prepare for the large-scale access and delivery of the Consortium’s novel pediatric medication in endemic countries.
Schistosomiasis, a neglected tropical disease, is a highly prevalent parasitic disease in sub-Saharan Africa, which may cause disabling conditions such as anemia, malnutrition, and impaired childhood development. Although an effective existing treatment—in the form of PZQ tablets— is available, the tablets are difficult for pre-school-age children (PSAC) to swallow, have an unpleasant bitter taste, and cannot be administered by crushing the tablet. The PZQ Consortium, a global public-private partnership established in 2012, has developed an affordable, PSAC-friendly orally dispersible PZQ tablet formulation for schistosomiasis. The project is in Phase III, with a pivotal trial under way in Kenya and Ivory Coast to generate confirmatory data for registration.
Through its ADOPT program, the Consortium aims to identify approaches to ensure wide acceptance and equitable access to its treatment for PSAC suffering from schistosomiasis. The five-year program considers aspects ranging from technology transfers and logistics for local manufacturing and distribution of the drug, to social mobilization and acceptance by the population. To that end, the program will support studies in selected African countries, including Kenya and Ivory Coast.
Commenting on their renewed investment in the Consortium, Ms. Catherine Ohura, GHIT Fund CEO & Executive Director said: "We are very excited about our partnership with the Consortium since 2013, now entering into the final stage of the project. At GHIT, we believe medicines are invaluable with access and valueless without it. The ADOPT program will be a critical step in bridging R&D and access & delivery."
Dr. Michael Makanga, Executive Director, EDCTP said: “Following our previous investment in the Consortium’s late-stage clinical development program, we felt it important to support the implementation of the access program. Indeed, successful development and access to a suitable pediatric treatment of schistosomiasis – through this global public-private partnership – will be a tangible contribution towards the Sustainable Development Goals (SDGs) by ensuring that the preschool-age group is not left behind.”
“We are delighted that our funding proposals were favorably evaluated by both the GHIT Fund and EDCTP,” said Dr. Jutta Reinhard-Rupp, Chair of the Pediatric Praziquantel Consortium Board and Head of the Global Health Institute at Merck. “There are an estimated 50 million preschool-aged children in need of treatment and it is our goal to fill this treatment gap towards the elimination of this disease according to the WHO. The additional funding is indeed critical to confirm how best to reach very young patients.”
1. About schistosomiasis
Schistosomiasis (also known as bilharzia) is one of the most prevalent parasitic diseases in sub-Saharan Africa, caused by parasitic flatworms called schistosomes. It affects almost 240 million people, mainly in communities without access to safe drinking water and with poor sanitation, with an estimated number of deaths of about 200,000 per year. The parasites live within freshwater snails and infect humans by penetrating the skin. The disease can lead to chronic inflammation of the organs, which can be fatal but also to anemia, stunted growth, and impaired learning ability with devastating consequences for the lives of the young children.
2. About the Pediatric Praziquantel Consortium
The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to reduce the global disease burden of schistosomiasis by addressing the medical needs of infected preschool-age children. Its mission is to develop, register and provide access to a suitable pediatric praziquantel formulation for treating schistosomiasis in this age group. The pediatric formulation under investigation has been designed to be smaller, exhibit an improved palatability and be orally dispersible compared with the current commercial formulation. For more information, visit the Consortium website: www.pediatricpraziquantelconsortium.org
3. GHIT’s investment in the Pediatric Praziquantel Consortium
|Year||Development Stage||Investment Amount||Project Detail|
|2013||Phase I||JPY 186 M||
|2014||Phase II||JPY 485M||
|2016||Phase II||JPY 467M||
|2019||Phase III||JPY 452M||
 Adoption of Levo-Praziquantel 150 mg for schistosomiasis by endemic countries